Clinical Trials

MainTitle

Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02508064

First received: July 22, 2015
Last updated: September 7, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-663068
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Two-Part Study to Evaluate the Bioavailability of BMS-626529 Administered as Prodrug BMS-663068 From Prototype Low-Dose Extended-Release Tablets (Part 1) and Prototype Multi-Particulate Formulations (Part 2) Relative to the 600 mg Extended Release Tablet in Healthy Subjects

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Maximum observed concentration (Cmax) of BMS-626529 [ Time Frame: Day 1 to Day 4 of each period ]
  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529 [ Time Frame: Day 1 to Day 4 of each period ]
  • Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529 [ Time Frame: Day 1 to Day 4 of each period ]
Secondary Outcome Measures:
  • Safety of BMS-663068 will be measured by incidence of Adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation;, and results of clinical laboratory tests, vital signs, 12-lead ECGs, and Physical examination (PE) [ Time Frame: Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing ]
  • Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs [ Time Frame: Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing ]

Enrollment: 27
Study Start Date: August 3, 2015
Study Completion Date: November 5, 2015
Primary Completion Date: November 5, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Part 1
BMS-663068 1 × 600 mg extended-release (ER) tablet formulation
Drug: BMS-663068

BMS-663068

Experimental: Part 1: Prototype 1
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1)
Drug: BMS-663068

BMS-663068

Experimental: Part 1: Prototype 2
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2)
Drug: BMS-663068

BMS-663068

Experimental: Part 1: Prototype 3
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3)
Drug: BMS-663068

BMS-663068

Experimental: Part 1: Prototype 4
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4)
Drug: BMS-663068

BMS-663068

Experimental: Part 1: Prototype 5
BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5)
Drug: BMS-663068

BMS-663068

Experimental: Part 2
BMS-663068 1 × 600 mg ER tablet formulation
Drug: BMS-663068

BMS-663068

Experimental: Part 2: Prototype 1
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1)
Drug: BMS-663068

BMS-663068

Experimental: Part 2: Prototype 2
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2)
Drug: BMS-663068

BMS-663068

Experimental: Part 2: Prototype 3
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3)
Drug: BMS-663068

BMS-663068

Experimental: Part 2: Prototype 4
BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4)
Drug: BMS-663068

BMS-663068

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:

  • Males and females, 18 to 50 years of age, inclusive
  • Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
  • Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug


Exclusion Criteria:
  • Any significant acute or chronic medical illness
  • Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
  • Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat:

  • i) PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec
  • Exposure to any investigational drug or placebo within 12 weeks of study drug administration
  • Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen
(HBsAg), or HIV-1 and HIV-2 antibody

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02508064

Locations

United Kingdom
GSK Investigational Site
Nottingham, United Kingdom, NG11 6JS

Sponsors and Collaborators

ViiV Healthcare
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02508064   History of Changes  
Other Study ID Numbers: 206288  
  AI438-054  
Study First Received: July 22, 2015  
Last Updated: September 7, 2017  

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.